Search Results

Used during surgery to protect delicate tissue from trauma, absorb fluid and act as a filter to aspirate.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "Ultracell Absorbent Stick." This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. It is a regulatory approval document confirming substantial equivalence to a predicate device, not a technical report detailing performance studies.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device

Ophthalmic sponge drains are used during surgery to protect delica tissue from trauma, absorb fluids, and to act as a filter to aspirate.

Not Found

I'm sorry, but this document does not contain the information requested. The document is an FDA 510(k) clearance letter for the Ultracell Suction Sponge, which is a medical device used in ophthalmic surgery. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the letter does not include any details about:

• Acceptance criteria or reported device performance for a study.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Types of ground truth used.
• How ground truth for a training set was established.

This document is a regulatory approval, not a technical report on a device's performance study.

Ask a specific question about this device

Neuro sponge drains are used during surgery to protect brain tissue from trauma, absorb fluids and to act as a filter to aspirate.

Not Found

The provided documents are FDA letters regarding the 510(k) premarket notification for the "Ultracell Suction Sponge" (K972633 and K972634). These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The letters from the FDA specifically state that the devices are substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. This type of FDA clearance (510(k)) generally relies on demonstrating substantial equivalence to a predicate device rather than on the detailed clinical performance data often required for new higher-risk devices or premarket approval (PMA).

Therefore, based solely on the provided text, I cannot complete the requested tables and information. The document focuses on regulatory approval based on substantial equivalence, not on the detailed technical or clinical study data.

Ask a specific question about this device

Neuro sponges are used during surgery to protect the brain tissue from dryness, trauma, absorb fluids and act as a filter to aspirate.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding the "Ultracell Neuro Sponges." It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is solely a clearance letter approving the device for marketing based on substantial equivalence.

Therefore, I cannot provide the requested information in the format specified because the source material does not include it. The document confirms market clearance but does not detail the technical performance criteria or the studies conducted to establish that performance.

Ask a specific question about this device

This product is designed to provide a direct method to remove fog from the endoscope and laparoscope.

The use of an anti-fog solution aid to eliminate troublesome cloudiness which prevents clear vision and poor picture images. After application of the solution the device is ready for use. All ingredients are sterile. The solution will not harm the lens and can be used as often as necessary.

This 510(k) submission describes an anti-fog solution for endoscopes and laparoscopes, not a medical device that requires a study to demonstrate performance against acceptance criteria in the typical sense (e.g., accuracy, sensitivity, specificity). The submission is focused on demonstrating substantial equivalence to predicate devices for its intended use, which is simply to prevent fogging. Therefore, most of the requested information about acceptance criteria and study details for device performance (such as sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) is not applicable to this type of submission.

Here's a breakdown based on the provided text, highlighting what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the traditional sense for a performance study. The "performance" described is the solution's ability to eliminate troublesome cloudiness that prevents clear vision and poor picture images. The acceptance is based on the claim that "After application of the solution the device is ready for use." There are no quantitative metrics or thresholds provided in the document for this claim as it is a fundamental functional claim for an anti-fog solution.

2. Sample size used for the test set and the data provenance

Not applicable. No formal test set or corresponding data provenance is mentioned as this is a functional claim for an anti-fog solution, not a diagnostic or AI device requiring such validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" does not apply here. The effectiveness is a direct observation of the absence of fogging after application.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For a product claiming to prevent fog, the "ground truth" is simply the visual observation of whether fog is present or absent on the lens after application.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI device.

Summary of the Study (as inferred from the 510(k) submission):

The provided document is a 510(k) summary for a medical device called "Visual Endoscopic Non-Alcohol Ultracell Sponge (VENUS II) and Visual Endoscopic Non-Alcohol Urethane Sponge (VENUS I)" which also includes the "ULTRACELL ANTI-FOG KIT". The core "study" is the demonstration of substantial equivalence to predicate devices already on the market prior to May 28, 1976.

The "study" demonstrating the device meets its acceptance criteria is not a formal clinical trial or performance study with quantitative outcomes. Instead, it relies on:

• Statement of Intended Use: The device's purpose is "to provide a direct method to remove fog from the endoscope and laparoscope."
• Functional Claims:
  • It eliminates "troublesome cloudiness which prevents clear vision and poor picture images."
  • "After application of the solution the device is ready for use."
  • "The solution will not harm the lens."
  • "All ingredients are sterile."
• Substantial Equivalence: The FDA's review and determination that "the device is substantially equivalent for the indications for use stated... to devices marketed in interstate commerce prior to May 28, 1976." This implies that the sponsor provided information (chemical composition, manufacturing processes, safety data, etc., though not detailed in this specific document) that allowed the FDA to conclude that this new device is as safe and effective as existing legally marketed predicate devices for the same intended use.

In essence, for this type of basic anti-fog solution, the "study" is the submission itself, arguing that its properties and function are demonstrably similar to products already deemed acceptable by the FDA, therefore meeting its acceptance criteria by association and inherent functional design.

Ask a specific question about this device

The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions.

Not Found

Based on the provided documents, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the requested level of detail.

The documents are a 510(k) clearance letter and an "Indications For Use" statement for the "Ultracell Packing with Sleeve (Nasal Pack)". This type of submission (510(k)) is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through detailed performance studies with ground truth establishment, expert adjudication, or MRMC studies.

The provided information indicates:

1. Device: Ultracell Packing with Sleeve (Nasal Pack)
2. Regulatory Class: I (21 CFR 874.4100/Procode: EMX) - Devices in this class generally have lower risk and often do not require extensive clinical or performance studies for 510(k) clearance if their technological characteristics and indications for use are similar to predicate devices.
3. Indications For Use: "The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions."
4. Nature of Clearance: Substantial Equivalence to a predicate device marketed prior to May 28, 1976. This means the FDA determined the device is as safe and effective as a legally marketed device, not that it met specific quantitative performance metrics from a formal study as would be required for higher-risk devices or novel technologies.

Therefore, I cannot provide the requested information in the format of a table with acceptance criteria, study details, sample sizes, expert qualifications, or adjudication methods because these are typically not part of a Class I 510(k) submission for a device like a nasal pack. Such details would be expected for AI/ML-driven devices, diagnostic devices, or higher-risk therapeutic devices.

The documents only address the regulatory clearance through the 510(k) pathway based on substantial equivalence, not the detailed performance evaluation against specific, measurable acceptance criteria that would be relevant for an AI/ML device as implied by your questions.

Ask a specific question about this device

Sponge drains are used during surgery to protect delicate tissue from trauma, absorb fluids and to act as a filter to aspirate

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding the "Ultracell Suction Sponge" and indicates that the device has been found substantially equivalent to predicate devices. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics.

Therefore, I cannot provide the requested information based on the given text. The provided document is a regulatory approval, not a performance study report.

Ask a specific question about this device

Ask a specific question about this device